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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2008-01-16 to 2008-04-10
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented, scientifically sound GLP study performed according to OECD Guideline 423 and EU Method B.1 tris. However, 6 animals were dosed at once rather than dosing in steps with 3 animals per steps

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Certificate provided by Groupe Interministeriel Des Produits Chimiques
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Zirconium dioxide
Cas Number:
1314-23-4
Molecular formula:
ZrO2
IUPAC Name:
Zirconium dioxide
Constituent 2
Reference substance name:
Zirconium dioxide
EC Number:
215-227-2
EC Name:
Zirconium dioxide
IUPAC Name:
215-227-2
Details on test material:
- Name of test material (as cited in study report): CC10 Zirconium Oxide
- Physical state: white powder
- Analytical purity: >98% (considered at 100% for the study)
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Elevage JANVIER (53940 Le Genest St Isle ¿France)
- Age at study initiation: 8 weeks old
- Weight at study initiation: beteween 188g and 207 g
- Fasting period before study: 1 day
- Housing: Three healthy female rats were kept in solid-bottomed clear polycarbonate cages with a stainless steel mesh lid.
- Diet: foodstuff provided ad libitum; food was removed at D-1 and then redistributed 4 hours after the test item administration.
- Water: tap-water from public distribution system provide ad libitum
- Acclimation period: 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 22 degree C
- Humidity (%): 39 and 55%
- Air changes (per hr): not applicable
- Photoperiod (hrs dark / hrs light): 12 hours daily


IN-LIFE DATES: From: 2008-02-05 To: 2008-02-20

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: distilled water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: no data
- Amount of vehicle (if gavage): no data
- Justification for choice of vehicle: no data


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg body weight


DOSAGE PREPARATION (if unusual): The animals of treated group, received an effective dose of 2000 mg/kg body weight of the test item, diluted in distilled water and administered by gavage under a volume of 10 mL/kg body weight using a suitable syringe graduated fitted with an oesophageal metal canula.

Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 female rats
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed on day D0 (just before administering the test item) then on D2, D7, and D14.
Weight changes were calculated and recorded.
- Necropsy of survivors performed: yes; Only those organs likely to be modified in cases of acute toxicity were examined. Those presenting macroscopic anomalies can be removed and preserved in view to microscopic examinations.
- Other examinations performed: Systematic examinations were carried out to identify any behavioural or toxic effects on the major physiological functions 14 days after administration of the test item.
Observations and a mortality report were then carried out every day for 14 days.
Statistics:
no data

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality occurred during the study.
Clinical signs:
No clinical signs related to the administration of the test substance were observed.
Body weight:
The body weight evolution of the animals remained normal throughout the study.
Gross pathology:
The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes.
Other findings:
no data

Applicant's summary and conclusion

Conclusions:
The LD50 of CC10 Zirconium Oxide is higher than 5000 mg/kg body weight by oral route in the rat.